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The CXI™ Support Catheter is intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.

The CXI™ Support Catheter with hydrophilic coating is a braided, kink-resistant catheter designed to facilitate wire guide exchange, wire guide support and to provide a conduit for the delivery of saline solutions or diagnostic contrast agents. The CXI" Support Catheter will be available in catheter sizes of 2.6 and 4.0 French and with catheter lengths of 65, 90, 135, and 150 centimeters. The catheters will be supplied sterile and are intended for one-time use.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the CXI™ Support Catheter:

Summary:

The provided text describes a 510(k) premarket notification for the CXI™ Support Catheter. The core of the submission relies on demonstrating substantial equivalence to a previously cleared predicate device (CXI™ Support Catheter, K072724). This means the acceptance criteria are primarily focused on showing that the new device performs at least as well as, and is as safe and effective as, the predicate device, despite minor modifications in available sizes and coaxial use. The study presented is an animal study.

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document doesn't explicitly state quantitative "acceptance criteria" for each performance parameter (e.g., "pushability must exceed X newtons"). Instead, it states that the overall testing showed the devices were "adequate or better" in these parameters, supporting the claim of substantial equivalence. This is common in 510(k) submissions where comparison to a predicate is key.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample size (number of animals or trials). It simply states "Animal Testing."
• Data Provenance: The study was "Animal Testing," implying it was conducted in a controlled laboratory setting. The country of origin is not specified, but given the company (Cook Incorporated) is based in Bloomington, Indiana, USA, it's highly probable the testing was conducted within the USA or under US regulatory guidelines. It is a prospective study, as it describes tests performed to demonstrate performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is generally not applicable to a preclinical animal study involving medical devices like catheters. The "ground truth" here is the direct, observable physical performance of the catheter in the animal model. The assessment of "adequate or better" would likely have been conducted by the study investigators (engineers, veterinary staff, and potentially physicians) based on predefined metrics or observations relevant to catheter performance. The document does not specify the number or qualifications of these individuals.

4. Adjudication Method for the Test Set

Not applicable in the context of this preclinical animal study. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or data by multiple human experts, where there can be inter-reader variability. Here, the performance metrics are physical characteristics directly observed or measured during the animal procedure.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. An MRMC study involves human readers (e.g., radiologists) interpreting cases with and without AI assistance to measure differences in diagnostic accuracy or efficiency. The provided submission is for a medical device (catheter) and relies on preclinical (animal) testing to demonstrate substantial equivalence, not a diagnostic AI algorithm.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, this question is not applicable. The device in question is a medical catheter, not an AI algorithm. Therefore, there is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The ground truth used for the animal testing was the direct, observable and measurable physical performance of the catheter in the animal model, as assessed against expected performance parameters for such a device (e.g., ease of introduction, pushability, trackability, flexibility, torquability, withdrawal, and post-use integrity). This is a form of empirical ground truth based on experimental observation.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical instrument (catheter), not a machine learning model. Therefore, there is no "training set" in the context of AI. The "training" in manufacturing of such devices refers to internal process validation and quality control, not data-driven model training.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no training set in the context of an AI device.

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The Cordis ELITECROSS™ Support Catheter is intended to facilitate the intraluminal placement of diagnostic/ interventional devices beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, and to deliver saline or contrast medium. Additionally, ELITECROSS™ can be used as an accessory with the FRONTRUNNER® XP CTO Catheter.

The ELITECROSS™ Support Catheter is a single-use, 5F sheath-compatible sterile catheter designed to provide additional support to the distal portion of ancillary diagnostic/interventional devices, including the FRONTRUNNER® XP CTO Catheter, as well as to deliver saline or contrast medium. After crossing the occlusion with the ancillary device, the ELITECROSS™ may be used to facilitate placing a guide wire across the occlusion.

The ELITECROSS™ Support Catheter device is a single lumen torqueable tube containing a full-length PTFE inner liner that is surrounded by a stainless steel braid, which is further encompassed by a polymer jacket, and features a final external hydrophilic coating on the distal 40 cm of the catheter body. The proximal end utilizes a molded hub with a luer fitting for flushing, with winged tabs designed to facilitate maneuvering and torqueing in the vasculature, while the distal tip contains a radiopaque marker band for visibility under fluoroscopy. The ELITECROSS™ Support Catheter will be available in various configurations and several lengths. The ELITECROSS™ Support Catheter is provided sterile (by EO) and intended for single use only.

This document is a 510(k) Pre-market Notification for the ELITECROSS Support Catheter. It seeks to demonstrate substantial equivalence to a predicate device, the Cordis Micro Guide Catheter ELITE. Therefore, the information provided focuses on the substantial equivalence and performance testing compared to the predicate, rather than a standalone study proving the device meets de novo acceptance criteria for an AI/ML device.

Because this is a submission for a medical device (catheter) and not an AI/ML device, the typical acceptance criteria and study design elements you've requested for AI/ML performance (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are not applicable in the context of this document.

Instead, the "acceptance criteria" for a medical device like this are generally related to its functional performance, physical dimensions, material properties, and biological safety, demonstrating that it performs as intended and is as safe and effective as a legally marketed predicate device.

Here's how to interpret the provided information in relation to your request, keeping in mind the device type:

1. A table of acceptance criteria and the reported device performance

Based on the document, the "acceptance criteria" are implied by the performance characteristics tested, demonstrating equivalence to the predicate and ensuring the device functions as intended. The reported performance is that the device "meets applicable performance requirements" and "continues to meet all previous performance specifications" of the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in the provided document. For physical device testing, sample sizes are typically determined by statistical methods or industry standards but are not usually detailed in this summary section of a 510(k).
• Data Provenance: Not specified nor is it typically relevant for this type of physical device performance testing. The tests are benchtop, laboratory evaluations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This is not an AI/ML device where expert consensus on interpretations or diagnoses would be required for ground truth. Ground truth for a catheter involves objective physical and functional measurements (e.g., burst pressure, flow rate, dimensions).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. As above, this is for AI/ML interpretative tasks, not for physical device performance validation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is a physical medical device (catheter), not an AI/ML diagnostic or assistive tool. MRMC studies are not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a physical medical device. There is no algorithm or "standalone" performance in the AI/ML sense.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Objective Technical Measurements: The "ground truth" for this type of device testing consists of objective, quantifiable measurements of physical properties and performance characteristics (e.g., dimensions, burst pressure, flow rates, compatibility with other devices). These are typically verified against engineering specifications and industry standards.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

• Not Applicable. No training set is involved.

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